Americans who have high-risk exposures to Ebola in the current outbreak in Central Africa will have access to an antibody treatment that has shown great promise in animal testing but hasn’t yet undergone a clinical trial to show whether it is efficacious in people, the Department of Health and Human Services confirmed Thursday.
The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that helps develop medical countermeasures for rare and emerging diseases, and biological threats.
It is not clear how many doses of MBP-134 exist at present. STAT asked the company and was told Mapp Bio could not reveal the number because BARDA owned the doses.
An American doctor who contracted Ebola in the outbreak zone was flown last month to Germany for care; his wife, also a doctor, and their four children were also taken to Germany for quarantine. The ill physician, Peter Stafford, remains in care but is reportedly recovering. Another doctor from the same Christian missionary group who had what was considered a high-risk exposure is in quarantine in the Czech Republic; he remains healthy. There are currently no other known exposures among Americans.
An expert panel advising the World Health Organization on possible therapeutics that could be tested or used in this outbreak — occurring in the northeastern part of the Democratic Republic of the Congo and neighboring Uganda — deemed MBP-134 one of the products to be prioritized for testing.
“MBP-134 … represents a promising option for treatment at a single dose,” the technical advisory group said in a statement issued last week.
An HHS spokesperson, communicating by email with STAT on the condition their name not be used, said BARDA is coordinating a shipment of monoclonal antibodies “for potential use in high-risk Americans exposed to the virus.” The individual said the therapy would be used under the Food and Drug Administration’s “investigational use mechanisms,” which allow emergency utilization of treatments that haven’t yet been licensed.
The email from the HHS official did not say where the monoclonal antibodies were being shipped, but the U.S. government has been building a quarantine station in Kenya for Americans who have had exposure to Ebola. The 50-bed facility is also going to have high-containment beds for initial treatment of anyone who becomes ill.
If any Americans develop Ebola, the administration has said it will evacuate them to Europe for care — a plan that has been met with widespread criticism from people who work in public health and from the population of Kenya. Opening of the containment camp, which was supposed to occur on May 29, was halted by a Kenyan court. There have been violent protests in the country in opposition of the plan.
Still, the Trump administration appears intent on proceeding with the containment camp, with Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services, saying earlier this week that officials anticipate they are going to be able to “work out something with Kenya.” The administration has insisted people who have Ebola or are at high risk of having been infected will not be allowed into the United States until they have been cured or have gone through quarantine for the 21-day incubation period.
The administration argues it’s faster to get sick people to high-level care in Europe than to fly them back to the U.S., even though the latter approach was used during the West African Ebola outbreak of 2014-2016 and U.S. taxpayers have spent millions of dollars on a network of high-containment facilities built expressly for this purpose. All but one of the eight repatriated individuals survived.
MappBio was founded in 2003 to develop medical countermeasures for the prevention and treatment of infectious diseases, with a particular focus on unmet needs in global health and biodefense, the company’s website states. It has been working on Ebola monoclonal antibodies for years.
MBP-134 is believed to be a pan-Ebola therapy, able to enhance chances of survival regardless of the species of Ebola infecting people who need treatment. This outbreak is caused by the Bundibugyo ebolavirus; it is only the third time in recorded history that this version of the virus has triggered an outbreak. Testing in primates suggests MBP-134 is effective against Bundibugyo as well as the Zaire and Sudan ebolaviruses.
But only a clinical trial can determine if the therapy works in people. And outbreaks such as this one provide the sole opportunity to conduct that kind of a clinical trial.
The U.S. government has not yet confirmed that it will provide doses of MBP-134 for a clinical trial. At a press conference last week, an administration official acknowledged that a request had been made for supplies of the drug to be used in a clinical trial. The official was non-committal. “We are working to assess the availability and to best identify how to distribute and utilize the courses that we have,” the official said.
However, people planning the clinical trials that will take place in this outbreak are hopeful MBP-134 will be among the treatments tested.
“The partners’ protocol is in front of the Congolese regulatory authorities,” said Armand Sprecher, an emergency physician and a veteran of Ebola outbreak responses who works with Doctors Without Borders. “They’ve got their ethical review done. The folks from the Institute of Tropical Medicine in Antwerp are poking around in Ituri” — the epicenter of the outbreak — “doing site evaluations. All the machinery is in motion.”